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NCT05742490 Clinical Trial

Neonatal Infection Surveillance Database

Neonatal Infection Clinical Trial

— neonIN  

Official title:
Neonatal Infection Surveillance Database

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05742490
Other study ID # 05.0093
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 16, 2013
Est. completion date November 22, 2028

Study information
Verified date January 2023
Source St George's, University of London
Contact Sana Ibrahim, BSc
Phone +44 (0)208 725 5382
Email sibrahim@sgul.ac.uk
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

NeonIN is a is a neonatal infection surveillance database which will facilitate active surveillance for bacterial infections through a network of neonatal units, using standardised definitions, proformas and microbiological techniques. The centralised and secure web-based database will allow real-time entry of data and rapid and timely analysis of results.

Description:

The neonIN surveillance network captures data on episodes of invasive neonatal infection on a web-based database (www.neonin.org.uk). Over 25 UK neonatal units currently contribute to this database in real-time. An episode of neonatal infection is defined as a positive culture collected from a normally sterile site such as the blood, cerebrospinal fluid (CSF) or urine (via catheter or suprapubic aspirate) for which clinicians prescribed at least five days of appropriate antibiotics. Clinical, demographic and microbiological data (including antimicrobial susceptibilities) are collected using a standardised online questionnaire, and denominator data regarding the total number of live-births and neonatal-admissions are collected for each neonatal unit.

Recruitment information / eligibility
Status Recruiting
Enrollment 12000
Est. completion date November 22, 2028
Est. primary completion date November 22, 2023
Accepts healthy volunteers
Gender All
Age group 1 Minute to 12 Months
Eligibility Inclusion Criteria: - Infants on participating Neonatal Units who have an episode of infection with a positive culture Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom St George's University of London London

Sponsors (1)
Lead Sponsor Collaborator
St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

Cailes B, Kortsalioudaki C, Buttery J, Pattnayak S, Greenough A, Matthes J, Bedford Russell A, Kennea N, Heath PT; neonIN network. Antimicrobial resistance in UK neonatal units: neonIN infection surveillance network. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F474-F478. doi: 10.1136/archdischild-2017-313238. Epub 2017 Oct 26. — View Citation

Cailes B, Kortsalioudaki C, Buttery J, Pattnayak S, Greenough A, Matthes J, Bedford Russell A, Kennea N, Heath PT; neonIN network. Epidemiology of UK neonatal infections: the neonIN infection surveillance network. Arch Dis Child Fetal Neonatal Ed. 2018 Nov;103(6):F547-F553. doi: 10.1136/archdischild-2017-313203. Epub 2017 Dec 5. — View Citation

Gkentzi D, Kortsalioudaki C, Cailes BC, Zaoutis T, Kopsidas J, Tsolia M, Spyridis N, Siahanidou S, Sarafidis K, Heath PT, Dimitriou G; Neonatal Infection Surveillance Network in Greece. Epidemiology of infections and antimicrobial use in Greek Neonatal Units. Arch Dis Child Fetal Neonatal Ed. 2019 May;104(3):F293-F297. doi: 10.1136/archdischild-2018-315024. Epub 2018 Jun 28. — View Citation

Sapuan S, Kortsalioudaki C, Anthony M, Chang J, Embleton ND, Geethanath RM, Gray J, Greenough A, Lal MK, Luck S, Pattnayak S, Reynolds P, Russell AB, Scorrer T, Turner M, Heath PT, Vergnano S. Neonatal listeriosis in the UK 2004-2014. J Infect. 2017 Mar;74(3):236-242. doi: 10.1016/j.jinf.2016.11.007. Epub 2016 Nov 17. — View Citation

Wang J, Kortsalioudaki C, Heath PT, Buttery J, Clarke P, Gkentzi D, Anthony M, Tan K; neonIN network. Epidemiology and healthcare factors associated with neonatal enterococcal infections. Arch Dis Child Fetal Neonatal Ed. 2019 Sep;104(5):F480-F485. doi: 10.1136/archdischild-2018-315387. Epub 2018 Nov 13. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of infection Collection of neonIN data on episodes of significant neonatal bacterial infections in NNUs recruiting to neonIN 6 months
Primary Antibiotic susceptibility Collection of neonIN data on susceptibility profiles of significant neonatal bacterial infections 6 months
Primary Features of bacterial infections Collection of neonIN data on gestation, birth weight, age of onset, clinical presentation and prior antibiotic use of significant neonatal bacterial infections 6 months
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